FDA UDI
In Commercial Distribution
🇺🇸 United States
GLOBAL HEALTHCARE
DI: 00872237004263
·
Model: UB-PC
·
GHC HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GLOBAL HEALTHCARE
- Primary DI
- 00872237004263
- Version / Model
- UB-PC
- Company Name
- GHC HEALTHCARE, INC.
- Labeler DUNS
- 884718776
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- 26dbe363-96ce-4566-a988-54d7c1be0a5b
Device Description
URINE BAG, 2,000ML, PEAR SHAPE, ANTI REFLUX VALVE, HANGER, SAMPLING PORT, FLUID PATHWAY STERILE.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58921 | Non-wearable adult urine collection bag, open-ended | A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40872237004261 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 00872237004263 | GS1 |